Evaluating a new treatment regimen for patients with multidrug-resistant TB (MDR-TB)
- Disease/Condition
- Infections and Infestations; Infections and Infestations
- Intervention type
- drug
- Primary sponsor
- university of Cape Town Lung Institute
- Funder
- Medical Research Council
- Location
- South Africa
- Phase
- Not Applicable
- Start date
- Jan 01, 1900
- End date
- Jan 01, 1900
Objectives1-To evaluate the impact of a new injection-free 6-month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional empiric injection-based regimen of kanamycin, moxifloxacin, PZA, ethionamide, terizidone, and potentially other group 5 drugs (21-24 months as DoH 2012 policy is to continue for 18 months after sputum conversion). A gene-directed diagnostic approach (mutational analysis using the Hain platform) will be used in the interventional arm to individualise therapy and to inform on the use of high dose INH versus ethionamide.2-To evaluate the impact of ART on bedaquiline concentrations in HIV-infected participants in the interventional arm. This information is critically needed to minimise the development of resistance to bedaquiline. An additional sub-aim will be to evaluate the PK/PD relationships of linezolid.
- Registry
- Pan Africa Clinical Trials Registry
- Trial ID
- PACTR201409000848428
- Type
- Non-Device Trial
Access comprehensive clinical trial information for PACTR201409000848428 through Pure Global AI's free database. This Not Applicable trial is sponsored by university of Cape Town Lung Institute and is currently Not yet recruiting. The study focuses on Infections and Infestations; Infections and Infestations.
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